HYDROMORPHONE HYDROCHLORIDE - hydromorphone hydrochloride tablet 
TAGI Pharma, Inc.

----------

Medication Guide

Hydromorphone Hydrochloride Tablets, USP CII


Hydromorphone Hydrochloride Tablets, USP are:

   •  Strong prescription pain medicines that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid analgesic, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.

   •  Opioid pain medicines that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. 


Important information about Hydromorphone Hydrochloride:

   • Get emergency help right away if you take too much Hydromorphone Hydrochloride Tablets, USP (overdose). When you first start taking Hydromorphone Hydrochloride Tablets, USP, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.

   • Taking Hydromorphone Hydrochloride Tablets, USP with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

   • Never give anyone else your Hydromorphone Hydrochloride Tablets, USP. They could die from taking it. Store Hydromorphone Hydrochloride Tablets, USP away from children and in a safe place to prevent stealing or abuse. Selling or giving away Hydromorphone Hydrochloride Tablets, USP is against the law.


Do not take Hydromorphone Hydrochloride Tablets, USP if you have:

   • severe asthma, trouble breathing, or other lung problems.

   • a bowel blockage or have narrowing of the stomach or intestines.


Before taking Hydromorphone Hydrochloride Tablets, USP, tell your healthcare provider if you have a history of:

   • head injury, seizures

   • problems urinating

   • abuse of street or prescription drugs, alcohol addiction, or mental health problems.

   • liver, kidney, thyroid problems

   • pancreas or gallbladder problems


Tell your healthcare provider if you are:

   • pregnant or planning to become pregnant. Prolonged use of Hydromorphone Hydrochloride Tablets, USP during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

   • breastfeeding. Hydromorphone Hydrochloride Tablets, USP pass into breast milk and may harm your baby.

   • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Hydromorphone Hydrochloride with certain other medicines can cause serious side effects that could lead to death.


When taking Hydromorphone Hydrochloride:

   • Do not change your dose. Take Hydromorphone Hydrochloride exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.

   •  Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.

   •  Call your healthcare provider if the dose you are taking does not control your pain.

   •  If you have been taking Hydromorphone Hydrochloride Tablets, USP regularly, do not stop taking Hydromorphone Hydrochloride Tablets, USP without talking to your healthcare provider.

   • After you stop taking Hydromorphone Hydrochloride Tablets, USP flush any unused tablets or liquid down the toilet.


While taking Hydromorphone Hydrochloride DO NOT:

   • Drive or operate heavy machinery, until you know how Hydromorphone Hydrochloride Tablets, USP affects you. Hydromorphone Hydrochloride can make you sleepy, dizzy, or lightheaded.

   • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Hydromorphone Hydrochloride Tablets, USP may cause you to overdose and die.


The possible side effects of Hydromorphone Hydrochloride Tablets, USP: 

   • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.


Get emergency medical help if you have: 

   •  trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.


These are not all the possible side effects of Hydromorphone Hydrochloride Tablets, USP. Call your doctor for medical advice about side effects. You may report side effects to Elite Laboratories, Inc., at 1-888-852-6657 or to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov 


Distributed by: Tagi Pharma, South Beloit, IL 61080


This Medication Guide has been approved by the U.S. Food and Drug Administration.


Issued: 01/2017


PI0004

Revised: 3/2018
TAGI Pharma, Inc.